MARK SHERMAN AND JESSICA GRESKO (Associated Press)
WASHINGTON (AP) — The Supreme Court said Friday it was temporarily maintaining federal rules on abortion drug use, but it will take time to more fully consider the issues raised in the court’s challenge. .
In an order signed by Judge Samuel Alito, the court imposed a five-day moratorium on the fast-moving case, prompting the judge to issue a lower court ruling limiting the Food and Drug Administration’s approval of the drug mifepristone. You can decide whether to allow effect in the short term.
The judge is only asking at this point to determine which parts of the April 7 ruling by U.S. District Judge Matthew Kaksmalik of Texas were amended by Wednesday’s appeal. It is The order expires late Wednesday, suggesting the court will decide the matter by then.
Less than a year after a conservative judge overturned Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright, courts are immersed in a new battle involving abortion. I noticed that there is
The administration of President Joe Biden and New York-based Danko Laboratories, the maker of the pill, have called on judges to intervene.
White House spokesperson Carine Jean-Pierre said in a statement Friday evening that the administration continued to “support evidence-based FDA approval of mifepristone and have it reviewed, approved and regulated by an independent agency of the FDA. will continue to support,” he said. A wide range of prescription drugs. “
She said, “In the face of continued attacks on women’s health, the stakes in this fight have never been higher. We will continue to fight to restore Roe v. Wade’s protection.” ”
Attorneys for anti-abortion doctors and medical organizations that are suing over mifepristone said Friday’s court decision was “standard operating procedure,” and the appeals court-ordered changes will be made by the middle of next week. I asked the judge to validate it.
An administrative stay, the type of order the court issued on Friday, usually doesn’t indicate what the judge will do going forward. Alito was signed because he is dealing with urgent papers from Texas. Alito is also the author of last year’s opinion overturning Roe v. Wade.
Both the Department of Justice and Danko have called women “regulatory chaos” if the Supreme Court does not block lower court rulings that have had the effect of tightening FDA rules allowing the prescription and dispensing of the drug mifepristone. warned of the harm of
Without court action, the new restrictions would have come into effect on Saturday.
The Biden administration and Danko now want a more permanent order that will keep the current rules as long as the legal battle over mifepristone continues. As a fallback, they asked the court to take up the issue, hear the debate, and decide on legal challenges to mifepristone filed by anti-abortion doctors and medical institutions by around last summer.
Rarely has a court allowed a full review of a case so quickly before at least one court of appeals thoroughly investigated the relevant legal issues.
A Fifth Circuit Court of Appeals ruling late Wednesday banned the pills used in the most common method of abortion from being mailed or prescribed without first seeing a doctor in person. It would also withdraw the Food and Drug Administration’s approval for the use of mifepristone beyond 7 weeks of gestation. FDA says 10 weeks is safe.
Still, the Court of Appeals has not outright withdrawn FDA approval of mifepristone amid ongoing controversy surrounding it. The Fifth Circuit narrowed the April 7 decision by US District Judge Matthew Kacsmaryk. The ruling was a sweeping and virtually unprecedented order that would have prevented the FDA from approving the pill. He gave the administration a week to appeal.
“This is the first time, to the Government’s knowledge, that a court has quashed FDA’s conditions for approving a drug based on inconsistencies with FDA’s safety judgments, after those conditions were in effect for many years. So much more,” wrote Prelogar.
Challenger’s attorney, Erin Hawley, said in a statement that the FDA is prioritizing politics over health concerns in its actions on medical abortion.
“The Fifth Circuit Court of Appeals rightly called on government agencies to prioritize women’s health by restoring key safeguards, and we hold the Supreme Court accountable. I urge you to do so.”
Mifepristone was approved by the FDA over 20 years ago and is used in combination with a second drug, misoprostol.
Adding to the uncertainty, another federal judge in Washington on Thursday clarified his own order last week, urging the FDA to keep mifepristone on the market in 17 Democratic-led states. , revealed that it would not do anything that might interfere with the availability of mifepristone.
It’s unclear how the FDA will be able to comply with the court orders in both cases in a situation Prelogar said Friday it couldn’t support.
Department of Health and Human Services Secretary Xavier Becerra said in a statement Friday night that the April 7 exclusion from Texas “poses an existential threat to the FDA’s ability to review and approve a wide range of drugs. , no FDA-approved drug will be safe from these attacks.”
Data collected by the Guttmacher Institute, a research group that advocates for abortion rights, shows a significant surge in the use of medical abortion after the FDA’s 2016 rule expansion. In 2017, medical abortion accounted for 39% of abortions, but by 2020 it had risen to become the most common method, accounting for 53% of all abortions.
Experts say the use of medical abortion has increased since the court overturned Roe.
When the drug was first approved, the FDA restricted its use to the seventh week of pregnancy. The first was for mifepristone, the second was for misoprostol, her second drug, and the third was for a complication. It also required physician oversight and a reporting system for serious drug consequences.
If the Court of Appeal action is valid, they again become the conditions under which mifepristone is currently dispensed.
At the heart of the Texas lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed.
Mifepristone has been used by millions of women for the past 23 years. While not dramatic enough to completely overturn drug approval, the latest ruling still represents a severe challenge to the FDA’s authority to oversee how prescription drugs are used in the United States.
Common side effects of mifepristone include cramping, bleeding, nausea, headache, and diarrhea. Rarely, surgery may be needed to stop the bleeding.
Still, in easing restrictions on mifepristone, FDA regulators cited a “very low incidence of serious adverse events.”
As of June 2022, more than 5.6 million women in the United States were using the drug, according to the FDA. During that period, the agency received her 4,200 reports of complications in women, which was less than her 1/10th of her 1% of women taking the drug.
Associated Press writers Paul Weber of Austin, Texas and Lindsay Whitehurst of Washington contributed to this report.
https://www.mcall.com/2023/04/14/high-court-temporarily-blocks-restrictions-on-abortion-pill/ Supreme Court Temporarily Blocks Restrictions on Abortion Drugs – The Morning Call